On August 19, 2020, the U.S. Department of Health and Human Services announced its Third Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19. The Declaration preempts state law and authorizes licensed pharmacists to order and administer, and pharmacy interns to administer, all vaccines recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP), and approved or licensed by the FDA, to children ages 3 to 18 during the COVID-19 pandemic.
Below is information being included in updated emergency guidance that is going to all pharmacists in the state with the attached handout for parents/patients. The Office of Professional Regulation and Board of Pharmacy have expressed similar concerns to ours in terms of communication, input in to the registry among other factors, which may limit the uptake. We have also heard of lack of reimbursement for the administration of vaccines to pharmacists in Vermont at least for DVHA, so another barrier for implementation. We will be following this closely, and providing input so please review and send your feedback to Stephanie.
Requirements of the amendment:
- The vaccine must be FDA-approved or licensed.
- The vaccination must be ordered and administered according to the CDC’s ACIP-immunization schedules.
- The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE)—ACPE training is also required for licensed or registered pharmacy interns. Pharmacists must also complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period
- The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.
- The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including:
- Informing the patient’s primary-care provider when available,
- Submitting the required immunization information to the State or local immunization information system (Vermont’s Vaccine Registry),
- Complying with requirements with respect to reporting adverse events, and
- Complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.
- The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate.
- Vermont Department of Health Immunization Registry (to apply for IMR account, find help line, general information about IMR; for questions about how to submit a batch file, call IMR Manager 802-951-4094) https://www.healthvermont.gov/health-statistics-vital-records/registries/immunization
- Using Registry in Emergency Tutorials
- How to manually enter an immunization quickly https://youtu.be/PqkGfWRktB4
- How and why to add vaccine to library https://youtu.be/8SBauz0Ixoc
- How to manually add a patient https://youtu.be/NxKQj288y80
- How to Use Vaccine Forecaster https://youtu.be/lM45xc1WDW8
- CDC’s ACIP-Immunization Schedules https://www.cdc.gov/vaccines/schedules/hcp/index.html
- 18 V.S.A. § 1129 Immunization Registry https://legislature.vermont.gov/statutes/section/18/021/01129 v2020-9-16
- 18 V.S.A. § 1132 Vaccine Adverse Event Reporting System https://legislature.vermont.gov/statutes/section/18/021/01132
A pharmacist may obtain a National Provider Identification (NPI) number and order vaccines directly. A pharmacist without an NPI number may order through a collaborative practice agreement with a v2020-9-16 prescriber. A standing order for adult vaccination may be amended with the express written permission of the prescriber who issued the order.
Vermont Immunization Registry (IMR)
Before administering any pediatric vaccine, a pharmacist must review of each patient’s current IMR “forecaster,” the patient record of vaccines administered and due. Immunizations must be reported into the IMR via HL7, batch, or direct entry. Immunizations should also be communicated to the child’s pediatrician.
All significant adverse events that occur after vaccination, even if the immunizing health practitioner is unsure whether a vaccine caused the adverse event, shall be reported into the Vaccine Adverse Event Reporting System.
Most Vermont payers supply funds to, and participate in, the Vermont Child Vaccine Program (VCVP), which includes the federal Vaccines for Children (VFC) Program, administered by the Vermont Department of Health Immunization Program. The Immunization Program purchases and oversees distribution of pediatric vaccines to provider offices at no charge, for use in all children under 19 years of age. For this reason, pharmacies wishing to offer pediatric vaccinations should verify insurers’ payment policies.
Pharmacies wishing to provide childhood vaccination services must provide a private space for administration.
Mandatory Information Sheet
Prior to immunizing a child, a pharmacist or delegate shall furnish the child’s caregiver the informational flyer appended to this guidance.